CN105534948B - A kind of vagina active bacteria formulation and preparation method thereof being stored at room temperature - Google Patents
A kind of vagina active bacteria formulation and preparation method thereof being stored at room temperature Download PDFInfo
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- CN105534948B CN105534948B CN201510958998.0A CN201510958998A CN105534948B CN 105534948 B CN105534948 B CN 105534948B CN 201510958998 A CN201510958998 A CN 201510958998A CN 105534948 B CN105534948 B CN 105534948B
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- active bacteria
- vagina
- bacteria formulation
- capsule
- lactobacillus delbrueckii
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
Abstract
The invention discloses the active bacteria formulations and preparation method thereof that one kind can treat bacterial vaginosis BV, by the way that Lactobacillus delbrueckii bacterium powder is prepared into Lactobacillus delbrueckii micro-capsule in the way of fluidized-bed coating machine side spray, and treated that modified starch is mixed and made into capsule with microwave drying technology, which can save under normal temperature conditions 12 months.The preparation method of the active bacteria formulation of vagina disclosed in this invention is practical, easy to operate, the period is short, step is easy rationally, has the advantages that at low cost, yield is high, suitable for scale production.
Description
Technical field
The invention belongs to biopharmaceutical technologies, and in particular to the vagina that one kind can treat bacterial vaginosis BV uses viable bacteria
Preparation and preparation method thereof, the active bacteria formulation have stronger storage stability under normal temperature conditions.
Background technique
Microecology in vaginas system is important one of the microecosystem of human body.There are many micro- lifes for field planting in healthy women vagina
Object, most common have lactobacillus, staphylococcus, a streptococcus, enterobacteria, enterococcus, corynebacteria, bacteroid, Candida albicans,
Mycoplasma, virus etc., they together constitute the normal flora of vagina.In vagina normal flora generally acknowledged at present it is most important at
Member is lactobacillus, it is the permanent bacterium of normal vagina.Its separation rate is 80%~100% in vaginal discharge sample, number
Amount is up to 8 × 107CFU/mL, other various bacterium are non-physiologic bacterium or conditioned pathogen.Vagina normal flora balance occurs
After imbalance, since lactobacillus is reduced or is disappeared, not only certain members in vagina normal flora may restrict excessively because losing
Growth, the pathogen in some external worlds may also can invade and be colonized because losing barrier, so as to cause bacterial vaginosis BV.
Bacterial vaginosis BV is the common disease of women, frequently-occurring disease.It is clinically anti-to use at present for bacterial vaginosis BV
Element is given birth to as essential therapeutic arsenals, but curative effect is unsatisfactory, and there are many drawbacks using antibiotic treatment bacterial vaginosis BV.It is main
It shows: inducing the emergence of endurance strain, it is lower and lower so as to cause the curative effect of antibiotic；Cause two double infection of patient
Dye even multiple infection and increasingly heavier toxic reaction and allergic reaction, and antibiosis is known as great blindness: and it can
To inhibit or kill pathogenic bacteria, but also inhibit or kill beneficial physiological bacterium simultaneously；Although may control momentaryly
Pathogenic bacteria, but more seriously destroy the balance of microecology in vaginas.
Currently, the study shows that:, by increasing the quantity of intravaginal lactobacillus, can adjust using living preparation of lactobacillus product
Microecology in vaginas balance, to achieve the purpose that treat bacterial vaginosis BV.Foreign countries are in terms of vagina living preparation of lactobacillus product
Research it is more early.Early in 1894, Doderlein thought: lactobacillus is the bacterium being present in vaginal fluid, and infers it
It plays an important role to the health of vagina.Ozmen S et al. proposes three kinds for the treatment of methods for treating bacterial vaginosis BV
Suppository of the test group containing lactobacillus acidophilus, clinical study results show that living preparation of lactobacillus preparation is treating all kinds of vaginitis
And prevent vaginitis recurrence aspect from having preferable curative effect.Chinese patent application (CN101543514A) discloses a kind of Composite Milk
The preparation method of the clean negative conditioning liquid of sour bacterium.
However, current relevant probiotics preparation but existing defects in use.Although in Tiny ecosystem active bacteria formulation
Although probiotics has many important physiological functions to body, desired treatment, health-care effect are obtained, probiotics is necessary
Reach enough quantity.Due to probiotics itself it is more fragile and it is easy influenced by ambient environmental factors, especially in micro- life
In the case that state viable bacteria product is placed in normal temperature condition for a long time, cause probiotics survival period in product short, after it enters body
Probiotics quantity is caused to reduce and cannot effectively play its prebiotic effect.Chinese patent application (CN1184637A) discloses one kind
The Lemonal of vaginopathy is treated, but the viable count in its preparation just reduces half or so after 3 months.Therefore, how
It effectively improves the storage stability of probiotics under normal temperature conditions and has become current urgent problem to be solved.
Summary of the invention
In view of the above technical problems, the first purpose of this invention is to make De Shi newborn by fluidized bed side spray granulating process
Bacillus bacterium powder and maltodextrin form Lactobacillus delbrueckii micro-capsule.
Second object of the present invention is to provide a kind of vagina active bacteria formulation that can be stored at room temperature, it can be improved moral
The storage stability of family name's lactobacillus under normal temperature conditions.
Third object of the present invention is to provide a kind of preparation method of vagina active bacteria formulation that can be stored at room temperature.
Fourth object of the present invention is to provide a kind of product prevented and/or treat bacterial vaginosis BV.
For achieving the above object, the technical solution adopted by the present invention is that: the vagina that can be stored at room temperature of one kind uses viable bacteria
The preparation method of preparation, comprising the following steps:
1. Lactobacillus delbrueckii bacterium powder is placed on fluidized bed, the primary of stable structure is made in maltodextrin side spray to bacterium powder
Micro-capsule.Wherein 35-65 DEG C of the inlet air temperature of fluidized-bed coating machine, air mass flow 25-65m3/ h, atomizing pressure 0.5-4.0bar,
30-55 DEG C of temperature of charge, hydrojet rate 1-25ml/min, rotary speed 300-600r/min.
It is handled 1 hour 2. modified starch is placed in microwave dryer.Wherein the vacuum degree of microwave dryer is
0.07MPa, temperature are 75 DEG C.
3. the Lactobacillus delbrueckii micro-capsule in step 1 is mixed with the modified starch in step 2 by formula as below: modified
Starch 890g, magnesium stearate 10.0g, Lactobacillus delbrueckii micro-capsule 100g obtain the vagina active bacteria formulation that can be stored at room temperature.
The weight allocation ratio of medial vagina of the present invention active bacteria formulation is modified starch: magnesium stearate: Lactobacillus delbrueckii is micro-
Capsule is 80-100:1:5-15.
The bacterial strain used in the present invention is Lactobacillus delbrueckii, specifically, being Lactobacillus delbrueckii DM8909 bacterial strain.
The dosage form of vagina of the present invention active bacteria formulation is capsule, can be saved under normal temperature conditions 12 months, can
Prevention and/or treatment bacterial vaginosis BV, it is also possible to answering in the product of preparation prevention and/or treatment bacterial vaginosis BV
With vagina active bacteria formulation of the present invention confirms it safely and effectively after zoopery and human trial verifying.
The present invention is micro- by the way that Lactobacillus delbrueckii bacterium powder is prepared into Lactobacillus delbrueckii in the way of fluidized-bed coating machine side spray
Capsule, and treated that modified starch is mixed and made into capsule with microwave drying technology, which can be under normal temperature conditions
It saves 12 months.
The present invention has the advantages that
1, probiotics is prepared into micro-capsule using embedding techniques, the storage stability of product can be improved；
2, modified starch can make the Lactobacillus delbrueckii in product survive for a long time after microwave drying treatment, product stability
Preferably；
3, simple preparation process and simple preparation raw material are used, product can be made to reach and be stored at room temperature 12 months
Effect；
4, preparation method is practical, easy to operate, the period is short, step is easy rationally, at low cost, yield is high, suitable
The advantages of suitable large-scale production.
Specific embodiment
The preparation for the vagina active bacteria formulation that embodiment 1. can be stored at room temperature
(1) preparation of Lactobacillus delbrueckii micro-capsule
Lactobacillus delbrueckii DM8909 bacterial strain bacterium powder is placed on fluidized bed, it is steady that structure is made in maltodextrin side spray to bacterium powder
Fixed primary micro-capsule.Wherein 35-65 DEG C of the inlet air temperature of fluidized-bed coating machine, air mass flow 25-65m3/ h, atomizing pressure 0.5-
4.0bar, 30-55 DEG C of temperature of charge, hydrojet rate 1-25ml/min, rotary speed 300-600r/min.
It is less that Lactobacillus delbrueckii micro-capsule obtained observes adhesion between micro-capsule size is uniform and micro-capsule under 40 power microscopes, and
Microcapsule granule meso-position radius D50=157.6um, flow velocity 27.4s, the degree of compression 17.7%, angle of repose are 26.3 °.
(2) microwave drying treatment of modified starch
Modified starch is placed in microwave dryer and is handled 1 hour.Wherein the vacuum degree of microwave dryer is 0.07MPa,
Temperature is 75 DEG C.
The microwave drying result of modified starch:
1 modified starch microwave drying result of table
(3) preparation for the vagina viable capsule that can be stored at room temperature
Lactobacillus delbrueckii micro-capsule is mixed with modified starch by formula as below: modified starch 890g, magnesium stearate
10.0g, Lactobacillus delbrueckii micro-capsule 100g, the preparation after having mixed are mounted in using gelatin as in cylindrical shape rubber shell made of primary raw material
In capsule, capsule volume is 0.48ml, and viable count is 3.0 × 108CFU/g or so.
The stability test for the vagina viable capsule that embodiment 2. can be stored at room temperature
This stability test, selection carry out under conditions of 25 DEG C ± 2 DEG C of temperature, relative humidity 60% ± 10%, when
Between be 12 months, experimental result are as follows:
2 stability experiment result of table
The zoopery for the vagina viable capsule that embodiment 3. can be stored at room temperature is verified
Taking weight 24-26g female mice 5, every mouse vagina is built into 10mg vagina viable capsule, and daily one
It is secondary, continuous three days.Whether there is or not the symptoms such as red and swollen secretion for observation mouse health condition and introitus part from administration first day.Directly
To the 7th day, mouse answered that health, vagina is locally asymptomatic, weight should increase.If mouse is unhealthy, weight loss or appearance are above-mentioned
It is unqualified that symptom, which should sentence this batch of product,.
Its experimental result are as follows:
3 safety test result of table
The human trial for the vagina viable capsule that embodiment 4. can be stored at room temperature is verified
Clinical test has been carried out to 300 Patients with Bacterial Vaginosis in five local hospitals, by this 300 patients into
Row is randomly divided into three groups: control group (metronidazole group), test group A (vagina viable capsule group), experiment group B (drug combination group,
Metronidazole+vagina viable capsule), this three groups administration mode is respectively as follows:
Control group: before sleeping every night after cleaning vulva, metronidazole suppository is put into vagina deep, 1 piece every time, 1 time every night, is used in conjunction
7 days；
Test group A: before sleeping every night after cleaning vulva, being put into vagina deep with viable capsule for vagina, 1 tablet each time, every night 1
It is secondary, it is used in conjunction 10 days；
Experiment group B: before sleeping every night after cleaning vulva, being put into vagina deep for metronidazole suppository, and 1 piece every time, 1 time every night, even
With 7 days；Vagina is put into vagina deep with viable capsule every night later, 1 tablet each time, 1 time every night, is used in conjunction 10 days, medicine 17 is shared
It.
Test result are as follows:
4 human test results of table
Note: n represents patient's number.
The above, only presently preferred embodiments of the present invention, not to the present invention make in any form with substantial limit
System, all those skilled in the art, without departing from the scope of the present invention, when using disclosed above skill
Art content, and the equivalent variations for a little variation, modification and evolution made, are equivalent embodiment of the invention；Meanwhile it is all according to
According to the variation, modification and evolution of substantial technological any equivalent variations to the above embodiments of the invention, this is still fallen within
In the range of the technical solution of invention.
Claims (8)
1. the vagina active bacteria formulation that one kind can be stored at room temperature, which is characterized in that will in the way of fluidized bed side spray embedding treatment
Lactobacillus delbrueckii bacterium powder and microwave drying technology treated that modified starch is mixed and made into preparation, firstly, passing through fluidized bed packet
Clothing pusher side sprays granulating process and Lactobacillus delbrueckii bacterium powder is prepared into Lactobacillus delbrueckii micro-capsule；Secondly, modified starch is utilized microwave
Dry technology is handled；Finally, Lactobacillus delbrueckii micro-capsule, modified starch and magnesium stearate are mixed, obtaining can room temperature
The vagina active bacteria formulation of preservation；
The fluidized bed side spray granulating process is that Lactobacillus delbrueckii bacterium powder is placed on fluidized bed, in maltodextrin side spray to bacterium powder
The Lactobacillus delbrueckii micro-capsule of stable structure is made, wherein 35-65 DEG C of the inlet air temperature of fluidized-bed coating machine, air mass flow 25-
65m3/ h, atomizing pressure 0.5-4.0bar, 30-55 DEG C of temperature of charge, hydrojet rate 1-25ml/min, rotary speed 300-
600r/min。
2. vagina active bacteria formulation according to claim 1, which is characterized in that the microwave drying process of the modified starch
Parameter are as follows: vacuum degree 0.07MPa, 75 DEG C of temperature, drying time is 1 hour.
3. vagina active bacteria formulation according to claim 1, which is characterized in that vagina active bacteria formulation formula
Weight allocation ratio is modified starch: magnesium stearate: Lactobacillus delbrueckii micro-capsule is 80-100:1:5-15.
4. vagina active bacteria formulation according to claim 1, which is characterized in that the formula of the vagina active bacteria formulation
For modified starch 890g, magnesium stearate 10.0g, Lactobacillus delbrueckii micro-capsule 100g.
5. vagina active bacteria formulation according to claim 1, which is characterized in that the Lactobacillus delbrueckii is De Shi cream bar
Bacterium DM8909 bacterial strain.
6. vagina active bacteria formulation described in claim 1-3 any one, which is characterized in that the dosage form is capsule
Agent.
7. vagina active bacteria formulation described in claim 1-3 any one, which is characterized in that the preparation is under normal temperature conditions
At least save 12 months.
8. vagina active bacteria formulation described in claim 1-3 any one is in preparation prevention and/or treatment bacterial vaginosis BV
Product in application.
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| CN105995981A (en) * | 2016-05-19 | 2016-10-12 | 内蒙古双奇药业股份有限公司 | Full-nutrient formula food containing probiotic microcapsules and having special medical purpose and preparation method thereof |
| CN113755357A (en) * | 2020-06-04 | 2021-12-07 | 内蒙古伊利实业集团股份有限公司 | Lactobacillus preparation and application thereof |
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| CN1184637A (en) * | 1996-12-07 | 1998-06-17 | 大连医科大学科达药业有限公司 | Lactobacillus and prepn. contg. same for treating vaginopathy |
| CN103156063A (en) * | 2011-12-13 | 2013-06-19 | 北京大北农科技集团股份有限公司 | Production process of feeding lactobacillus microcapsule and microcapsule, application and premix thereof |
| CN104434999A (en) * | 2014-11-07 | 2015-03-25 | 南昌大学 | Preparation method of probiotic suppository and capsules for treating female inflammation |
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| US8444967B2 (en) * | 2010-07-09 | 2013-05-21 | Master Supplements, Inc. | Treatment including prebiotic composition for use with probiotics |
| US20090155354A1 (en) * | 2007-12-14 | 2009-06-18 | Mclean Barbara Wanamaker | Dispensing encapsulated liquids into body cavities |
| IT1403661B1 (en) * | 2011-01-28 | 2013-10-31 | Probiotical Spa | EFFERVESCENT COMPOSITION IN THE SOLID FORM FOR USE IN VAGINAL APPLICATIONS FOR THE TREATMENT OF VAGINAL INFECTIONS. |
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| CN1184637A (en) * | 1996-12-07 | 1998-06-17 | 大连医科大学科达药业有限公司 | Lactobacillus and prepn. contg. same for treating vaginopathy |
| CN103156063A (en) * | 2011-12-13 | 2013-06-19 | 北京大北农科技集团股份有限公司 | Production process of feeding lactobacillus microcapsule and microcapsule, application and premix thereof |
| CN104434999A (en) * | 2014-11-07 | 2015-03-25 | 南昌大学 | Preparation method of probiotic suppository and capsules for treating female inflammation |
| CN104546946A (en) * | 2014-12-17 | 2015-04-29 | 内蒙古双奇药业股份有限公司 | Preparation method of room-temperature preserved bifidobacteria enteric microcapsule |
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